Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

IMMUNOELECTROFILM KIH

K-Number: K770719 · 1977-04-26

ApplicantKallestad Laboratories, Inc.
Decision Date1977-04-26
Product CodeJZS
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IMMUNOELECTROFILM KIH is the device name listed in this FDA 510(k) record. The listed applicant is Kallestad Laboratories, Inc.. It received FDA 510(k) clearance on 1977-04-26 under 510(k) number K770719. The device is classified under product code JZS. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMUNOELECTROFILM KIH?

IMMUNOELECTROFILM KIH is a medical device that received FDA 510(k) clearance on 1977-04-26. The listed applicant is Kallestad Laboratories, Inc.. The 510(k) number is K770719.

When did IMMUNOELECTROFILM KIH receive FDA 510(k) clearance?

IMMUNOELECTROFILM KIH received FDA 510(k) clearance on 1977-04-26, under 510(k) number K770719.

Who is the listed applicant for IMMUNOELECTROFILM KIH?

The FDA 510(k) record lists Kallestad Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMMUNOELECTROFILM KIH?

The FDA product code for IMMUNOELECTROFILM KIH is JZS.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Kallestad Laboratories, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K863681PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEMK862917PATHFINDER ROTAVIRUS CHEMILUMINESCENTK863682PATHFINDER(TM) SPECIMEN COLLECTION KITK862743PATHFINDER(TM) RESPIRATORY SYNCYTIAL VIRUSK862313KALLESTAD SM/RNP TEST REAGENTK862710KALLESTAD SSA/SSB ENA TEST REAGENTS

View all 92 devices →

Related Devices (Code: JZS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K933123SYNELISA TG ANTIBODIES/TPO ANTIBODIESElias U.S.A., Inc.K812194IMMUNODIFFUSION BAND INTENSIFYING FLUIDAmerican Scientific ProductsK770566IMMUNOELECTROPHORESIS PROFILE KITKallestad Laboratories, Inc.K770718STAIN, R-250, COOMASSIE BRILLIANT BLUEKallestad Laboratories, Inc.K770150ELECTRO IMMUNO ASSAY KITMillipore Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑